HYBRESIS
Received Jan 4, 2011 · Event occurred Nov 22, 2010
Report 1721293-2010-00019 · MDR key 1952441
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
52 YR
- Skin Irritation
Narrative
Additional Manufacturer Narrative
THE DEVICE WILL NOT BE RETURNED FOR EVAL. A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THIS REPORT IS BEING SUBMITTED BECAUSE EMPI HAS RECEIVED A SIMILAR COMPLAINT THAT SUGGESTS THAT THIS DEVICE MAY HAVE MALFUNCTIONED IN SUCH A WAY THAT IT WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.
Description of Event or Problem
IT WAS REPORTED THAT PT SUFFERED A SKIN REACTION UNDER THE BATTERY AREA OF THE HYBRESIS PATCH. THE PT WAS BEING TREATED FOR BICIPITAL STRAIN WITH DEXAMETHASONE 1.5CC WITH A CONCENTRATION OF 4MG/ML. PT DID NOT SEEK MEDICAL ATTENTION FOR THE SKIN REACTION.